Pharmaceutical compositions containing testosterone and an aromatase inhibitor

Abstract

A pharmaceutical dosage comprising testosterone or an ester thereof and an aromatase inhibitor; the aromatase inhibitor may be selected from the group consisting of anastrozole, letrozole, and exemestane. In one embodiment the dosage is an implant. Also disclosed are therapies for patients with symptoms of relative androgen deficiency, breast cancer survivors and other therapies in which testosterone is indicated but elevated estradiol levels are avoided.

1 . A pharmaceutical dosage comprising testosterone or an ester thereof and an aromatase inhibitor. 
   
   
       2 . The dosage of  claim 1  wherein the aromatase inhibitor is selected from the group consisting of anastrozole, letrozole, and exemestane. 
   
   
       3 . The dosage of  claim 2  further including a pharmaceutically acceptable excipient. 
   
   
       4 . The dosage of  claim 3  wherein the dosage is a subcutaneous implant. 
   
   
       5 . The dosage of  claim 4  wherein the dosage contains about 30 to 200 mg. testosterone. 
   
   
       6 . The dosage of  claim 5  wherein the dosage contains about 1 to 90 mg. aromatase inhibitor. 
   
   
       7 . The dosage of  claim 6  wherein the excipient is capable of releasing the testosterone and the aromatase inhibitor into the blood at a controlled rate for a period of at least 30 days. 
   
   
       8 . The dosage of  claim 3  wherein the excipient is a lubricant or a binder or a combination thereof. 
   
   
       9 . The dosage of  claim 6  wherein the dosage is suitable for administration in an amount that provides less than 30 pg/ml estradiol level in the blood serum. 
   
   
       10 . The dosage of  claim 8  wherein the amount of excipient is less than about 5% by weight of the dosage. 
   
   
       11 . The dosage of  claim 10  wherein the aromatase inhibitor is anastrozole. 
   
   
       12 . The dosage of  claim 11  wherein the dosage contains testosterone. 
   
   
       13 . The dosage of  claim 12  wherein the dosage contains about 50 to 90 mg. testosterone. 
   
   
       14 . The dosage of  claim 13  wherein the dosage contains about 3 to 14 mg. aromatase inhibitor. 
   
   
       15 . The dosage of  claim 1  wherein the dosage provides approximately zero order release of testosterone.